QUANTRA

System, Image Processing, Radiological

HOLOGIC, INC.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Quantra.

Pre-market Notification Details

• Device ID: K082483
• 510k Number: K082483
• Device Name: QUANTRA
• Classification: System, Image Processing, Radiological
• Applicant: HOLOGIC, INC. 35 CROSBY DR. Bedford, MA 01730
• Contact: Catherine A Williams
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2008-08-28
• Decision Date: 2008-09-12
• Summary: summary